Two separate lawsuits and decisions issued on the same day last week regarding the Federal Drug Administration and its approval and rules around the abortion medication mifepristone has caused confusion over the drug’s legality in the day since then, but a federal district judge in Washington state clarified the drug’s status as legal in New Mexico late on Thursday.
Washington state federal district Judge Thomas Rice clarified that his decision last week to further lift FDA regulations on mifepristone will remain in effect in those 18 jurisdictions, including New Mexico, regardless of the conflicting decision released by the U.S. Fifth Circuit Court of Appeals late Wednesday night.
Rice issued his clarification that his decision holds true for the 17 states and the District of Columbia less than 24 hours after the U.S. Fifth Circuit Court of Appeals, based in New Orleans, determined that the FDA must return to how it regulated mifepristone prior to 2016.
The attorneys general in 17 states and the District of Columbia sued the FDA earlier this year asking the agency to lift its remaining restrictions on the abortion medication mifepristone. Rice, in eastern Washington, ruled last Friday in favor of the plaintiffs but his ruling came on the same day as Texas federal district Judge Matthew Kacsmaryk’s rule against the FDA restricting mifepristone.
Kacsmaryk’s opinion, in a case brought against the FDA by Christian-based Alliance for Hippocratic Medicine, placed a seven-day stay to allow the FDA to appeal his decision to the U.S. Fifth Circuit Court of Appeals.
The U.S. Fifth Circuit Court of Appeals, which has two Trump appointees and one George W. Bush appointee, ruled at midnight Wednesday that it split its decision and did not agree with Kacsmaryk that the Alliance for Hippocratic Medicine had merit in its case to sue the FDA’s original drug approval process 23 years ago. But the higher court ruled in partial agreement that it found that mifepristone carries risk and ruled that the FDA must return to its 2016 restrictions on mifepristone. But the higher court also ruled that the drug will remain available while the case continues through the court system.
Nonetheless, the two conflicting court opinions have created a sense of chaos and confusion. Ellie Rushforth, a reproductive rights attorney for the American Civil Liberties Union of New Mexico, said “these decisions are creating mass confusion for patients and providers and impacting the ability of our health care system to meet critical needs.
“We…applaud the [Washington] court’s reliance on actual science and experts in the field, rather than debunked misinformation and anti-abortion talking points.” Rushforth said.
The U.S. Department of Justice issued a statement on Thursday that it is seeking emergency relief from the U.S. Supreme Court on the Fifth Circuit Court of Appeals’ decision. When the Supreme Court ruled last year on the Dobbs v. Jackson Women’s Health Organization decision, it said, in part, that it believed the issue of abortion should be decided by Congress and individual states, who are answerable to by the voters, rather than through judicial review. The court also opined that by overturning Roe v. Wade in its Dobbs decision, there would be fewer legal battles over abortion.
New Mexico Attorney General Raúl Torrez’s office said that while mifepristone is legal in New Mexico, some clarification is still required.
“We support the Department of Justice’s appeal of the Fifth Circuit decision and look to the United States Supreme Court to clarify exactly what access to this medication looks like. We understand that the FDA’s approval of mifepristone is still valid for New Mexico; however, we still need clarification from the highest court on how the ruling impacts the mailing of mifepristone, if at all,” Lauren Rodriguez, a spokesperson for Torrez’s office, said via email.
Several states that have become abortion-safe havens, such as California and New York, have announced that they are stockpiling misoprostol, the second drug used in the two-drug regimen for abortion, in the event mifepristone becomes unavailable. Mifepristone blocks the hormone that enables a pregnancy to continue. Misoprostol initiates contractions. Misoprostol can be used alone for abortion but is considered slightly less effective than using both drugs combined.
Governor Michelle Lujan Grisham has not made a similar announcement but her office said on Thursday that she is “currently in conversations with other states on how we can collectively work to protect access to reproductive health care, including medication abortion.”
Over 400 pharmaceutical companies have signed an online petition asking the court to reverse Kacsmaryk’s decision in full. The petition says that the decades of data shows that mifepristone is safer than Tylenol and that allowing the FDA’s drug approval process to be legally challenged will impact the entire industry.
Eva Temkin, former FDA deputy director, said during a press conference with reporters on Thursday that the Fifth Circuit Court of Appeals’ decision to stand by at least part of Kacsmaryk’s ruling last week “opens the door for frivolous lawsuits and second guessing FDA’s scientific decisions.”
She said it could have a “chilling effect” on future drug innovations and research. She also called it “destabilizing.”
By requiring the FDA to return to mifepristone regulations prior to 2016 means that, at least in the 33 states where it would presumably be enforceable, an abortion patient would have to visit an abortion clinic three times to receive the drug and it would only be available up to 7 weeks of gestation. Since 2016, the FDA allowed medication abortion up to 10 weeks of gestation. Earlier in 2023, the FDA ended its in-person clinic requirement so that the medication could be sent through the mail.
As mifepristone has become more widely available through the FDA’s relaxation of its rules around the drug, the number of medication abortions has increased. By 2020, more than half of all abortions in the U.S. were medication abortions.
The Fifth Circuit Court of Appeals intends to rule again after more judicial review of Kacsmaryk’s decision. Its decision on late Wednesday was in response to the stay pending appeal, which gave the higher court only seven days to respond.
Jennifer Dalven, a reproductive rights attorney with the ACLU, said during the national press conference that she expects the FDA to issue guidance regarding the conflicting decisions, in addition to what decision the U.S. Supreme Court makes.